Overview

Like the agency itself, we have dedicated practices focusing on each segment of the Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA). We partner with stakeholders in the food, pharmaceutical, health and life sciences, and other impacted industries to navigate FDA regulations and agency interactions. From new medical devices and biotechnology to innovative food products and cosmetics, companies rely on us to guide them through every stage of product development. We partner with you to know your business and provide experienced advice to navigate the FDA — from product concept to creation.
Drugs and Medical Devices: As a drug and medical device innovator, your success relies on your ability to comply with a complex framework of regulations related to clinical development, marketing authorization, commercialization strategies and post-marketing compliance. We perform facility audits and advise on clinical trial contracting, internal compliance audits, due diligence reviews, expanded access, labeling, advertising, promotion, recalls, competitor issues, investigations, enforcement and related matters. With a team featuring former life science in-house counsel and U.S. attorneys, we bring valuable insight and experience to every matter we handle.

Food and Dietary Supplements: Leading food and dietary supplement companies confront critical legal, regulatory and business challenges every day. We help you develop and execute strategies related to the science, economics, markets, government regulation and public relations aspects of the farm to-table cycle. When disputes, regulatory changes or product recalls emerge, our regulatory and litigation teams provide peace of mind as you implement new compliance protocols or tackle high-stakes litigation.

Cosmetics: Makers of cosmetics and personal care products must continuously adapt and expand product offers to reflect the growing desire of consumers to express their beauty and individuality. Creative marketing and advertising of these products may exceed lawful conduct and result in enforcement action by regulatory agencies. States have become increasingly involved in cosmetic regulation as it relates to product ingredients and consumer health. We work with you to meet these emerging challenges head-on. We review product ingredients and advise on prospective advertising and labeling claims that are the basis for legal challenges by regulators and competitors.

Animal Health: Companies making new animal drugs, biologics, pet food, feed additives and animal feed rely on the in-depth knowledge we have gained in years of serving the animal health industry. We know regulatory requirements and help you identify and implement efficient development, manufacturing and marketing of animal food and drugs. We guide clients through interactions with the FDA and the United States Department of Agriculture. We provide the competitive advantage you need for success by delivering industry insight and practical advice on complex legal issues related to adverse event reporting, recalls, criminal investigations and product liability.

Experience

Our Experience

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